UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Acronym	Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Scientific Title	Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Scientific Title:Acronym	Randomized controlled study on the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The evaluation of the efficacy of the exercise and amino acid for the elderly with esophageal squamous cell carcinoma during neoadjuvant chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of skeletal muscle mass during neoadjuvant chemotherapy
Key secondary outcomes	The incidence of postoperative complications. The incidence of adverse events of chemotherapy. The change of CGA, body composition, body function, and QOL before chemotherapy, after chemotherapy, after surgery, and 1 year after surgery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Taking exercise with Power Plate for 10 days of the every neoadjuvant chemotherapy course. Nutritional intervention by the amino acid intake after exercise.
Interventions/Control_2	No exercise and no nutritional intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) the subjects aged 65 years or older with thoracic esophageal squamous cell carcinoma who will be intended to take surgery. 2) the subjects treated with neoadjuvant chemotherapy. 3) the subjects with written informed consent. 4) the subjects with the ability to intake amino acid (not necessarily oral intake, but also intake with feeding tube).
Key exclusion criteria	1) the subjects with effort angina, chronic heart failure and tachyarrhythmia. 2) the subjects with chronic respiratory failure. 3) the subjects not able to walk by themselves (ECOG-PS>=3). 4) the subjects with chronic kidney disease. 5) the subjects with severe hepatic dysfunction. 6) the subjects not able to take exercise. 7) the subjects with uncontrolled multiple primary cancer. 8) the subjects judged by the investigator to be unfit to participate in the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Yamasaki
Organization	Department of Gastroenterological Surgery Graduate School of Medicine Osaka University
Division name	Department of Gastroenterological Surgery Graduate School of Medicine
Zip code	565-0871
Address	2-2 Yamadaoka, E2, Suita, Osaka, Japan
TEL	06-6879-3251
Email	myamasaki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Norihiro Middle name Last name Matsuura
Organization	Department of Gastroenterological Surgery Graduate School of Medicine Osaka University
Division name	Department of Gastroenterological Surgery Graduate School of Medicine
Zip code	565-0871
Address	2-2 Yamadaoka, E2, Suita, Osaka, Japan
TEL	06-6879-3251
Homepage URL
Email	nmatsuura11@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka General Medical Center Tottori University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Department of Mrdical Innovation
Address	2-2, Yamadaoka, Suita, Osaka, Japan
Tel	06-6210-8290
Email	rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪大学（大阪府） 大阪急性期・総合医療センター（大阪府） 鳥取大学医学部（鳥取県）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 10 Month 15 Day
Date of IRB	2018 Year 10 Month 22 Day
Anticipated trial start date	2018 Year 10 Month 22 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 15 Day
Last modified on	2021 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039340